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VC Deals Analysis: Only Christmas Miracle Will Close Gap

As the end of the year approaches, medtech venture financing activity looks to have picked up in November to be on par with the previous year's level – but not enough to bridge the gap in annual performances.

StartUps and SMEs Financing Deals

EU Dismisses Call For 5-Year MDR Transition As Linguists And Lawyers Struggle To Finalize Text

Stakeholders have been pushing to have the planned transition period for the pending EU Medical Device Regulation extended from three to five years, but the EU Commission has so far resisted such a change, according to a key notified body official.

Europe Medical Device Policy & Regulation

Senate Poised To Vote On Cures Bill; Headed To Likely Enactment This Term

Following House passage of a combined House/Senate 21st Century Cures package Nov. 30, the Senate will take up the bill on Dec. 5 or 6, said Senate HELP Committee Chair Lamar Alexander, R-Tenn., who shepherded a similar package of medical innovation bills through the committee earlier this year. While some Democrats remain vocal in opposing the bill based on worries that it will water-down FDA safety protections and funding concerns, the House vote showed lopsided support, and the Senate is expected to pass it and the president to sign.

Policy & Regulation Legislation United States

21st Century Cures: Device Provisions

Dozens of reforms impacting the medtech sector were passed by the US House Nov. 30 in a compromise version of the 21st Century Cures Act that is expected to pass the Senate and be signed by President Obama before he leaves office. Here's a breakdown of the provisions most important to device- and diagnostic-makers.

Policy & Regulation Legislation Medical Device
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Q3 Recalls Snapshot: Numbers Continue To Rise; Software, Mislabeling Remain Top Reasons For A Recall

The number of device recalls continued to climb in 2016, with software and mislabeling causing the most troubles for manufacturers in the third quarter. They were the top two reasons for a recall.

Recalls Quality Control Policy & Regulation

Gottlieb Joins HHS Transition Team; Will Next Stop Be FDA?

Former US FDA, CMS official has been among those thought to be in the running for Trump's FDA commissioner nomination.

Policy & Regulation US Election 2016 Medical Device

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Device Week – December 2, 2016

On this week's podcast, we discussed the 21st Century Cures Act, which is headed towards likely enactment this year and includes an array of reforms to streamline the FDA process for medtech. Also, the Trump transition team’s picks for HHS and CMS. Finally, we talked about Edwards Lifesciences' recent acquisition of Valtech Cardio and key imaging industry product launches announced at this year's RSNA meeting.

Medical Device Diagnostics

Warning Letter Close-Outs – November 2016

US FDA released two device-related close-out letters in November.

Device Warning Letters Policy & Regulation

GOP's Greg Walden Of Oregon To Chair House Energy and Commerce

Congressional Republicans elected Rep. Greg Walden, R-Ore., to serve as the next chairman of the powerful House Energy and Commerce Committee, which oversees FDA issues, in 2017.

Policy & Regulation Legislation

FDA Off-Label Speech Guidance May Focus On Payers, Attorneys Say

Definitive guidance from FDA on off-label communications may be some time away and is likely to focus on physicians and payers before consumer-focused messaging, according to attorney from Arnall Golden Gregory.

Policy & Regulation Medical Device

Device Standards Provision In Cures Bill Could Speed Up 510(k) Clearances

Under a provision in the 21st Century Cures bill, which is accelerating towards enactment, FDA may need to consider recognizing more standards, which could speed up review times for 510(k)s. But it is also likely to add a burden for the agency.

Policy & Regulation Legislation

'Cures' Bill Circumvents FDA On Medical Software Regs

Lobbyists for the medical software industry, and particularly clinical decision support tools are "delighted" that lawmakers are getting around the agency by explicitly stating the types of software it is not allowed to regulate in the 21st Century Cures Act, set to pass Congress by the end of the year.

Policy & Regulation Legislation

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UK NICE Recommends FITs As 'More Accurate' Than Guaiac-Based Fecal Tests

A new draft guidance from the National Institute for Health and Care Excellence (NICE) recommends the NHS use fecal immunochemical tests (FITs), instead of guaiac-based tests, for detecting gastrointestinal bleeding associated with bowel cancer.

Health Technology Assessment In Vitro Diagnostics Gastrointestinal

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Device Week – December 2, 2016

On this week's podcast, we discussed the 21st Century Cures Act, which is headed towards likely enactment this year and includes an array of reforms to streamline the FDA process for medtech. Also, the Trump transition team’s picks for HHS and CMS. Finally, we talked about Edwards Lifesciences' recent acquisition of Valtech Cardio and key imaging industry product launches announced at this year's RSNA meeting.

Medical Device Diagnostics

Start-Up Spotlight: Arterys, Allowing More To Be Seen In Cardiac MRIs

Cardiac imaging software specialist Arterys has partnered with GE Healthcare to bring to market the first easy-to-use and comprehensive MRI tool for heart defects.

Cardiology Diagnostic Imaging

RSNA Brings Flood Of Imaging Product Launches

Product launches at the 2016 RSNA meeting in Chicago include new practice management and imaging software from Philips,

Commercial Innovation

World AIDS Day 2016: HIV Self-Testing Gets Boost From New WHO Guidelines

To mark this year's World AIDS Day on Dec. 1, the World Health Organization has expanded its guidelines on HIV testing that will help increase the uptake of HIV self-testing – and a likely boost for manufacturers of these products – and improve HIV partner notification services.

In Vitro Diagnostics Policy

Siemens Deal Rounds Off SyntheticMR's Big Imaging Hat Trick

SyntheticMR's latest agreement with Siemens Healthineers means the Swedish company now has imaging sector's top three players to help push its software technology that allows for faster MRI workflow and more quantitative and precise measurements.

Diagnostic Imaging Innovation

Edwards To Pay Up To $690m For Cardioband-Maker Valtech

The Cardioband system is a transcatheter annuloplasty device for repair of mitral and tricuspid valves that should be a natural fit with Edwards transcatheter mitral valve development program. Israel-based Valtech had a deal in September 2015 to be acquired by HeartWare for $900m, but that deal fell through after HeartWare investors protested.

Companies Deals

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Boston Scientific's Heart Failure Monitoring Service Shows Promise

Data from the MultiSENSE trial, presented at the American Heart Association meeting, shows Boston Scientific's planned HeartLogic alert service is able to predict impending heart failure events with 70% sensitivity and a low unexplained alert rate of 1.47 per patient per year.

Cardiology Innovation Clinical Trials

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Device Week – December 2, 2016

On this week's podcast, we discussed the 21st Century Cures Act, which is headed towards likely enactment this year and includes an array of reforms to streamline the FDA process for medtech. Also, the Trump transition team’s picks for HHS and CMS. Finally, we talked about Edwards Lifesciences' recent acquisition of Valtech Cardio and key imaging industry product launches announced at this year's RSNA meeting.

Medical Device Diagnostics

Neuronetics Launches Major Registry To Track NeuroStar TMS Outcomes

The registry will collect data from more than 6,000 depression patients treated with transcranial magnetic stimulation at more than 100 different treatment facilities in the US to better understand how the therapy benefits patients in the "real world."

Research & Development Innovation

New Data Gives Adherium Fuel To Accelerate Digital Tech Adoption in Drug Sector

With nearly 40 published peer-reviewed journal articles under its belt, Adherium is hoping that the latest clinical data which underlines the ability of the company's Smartinhaler to improve outcomes for children with poorly controlled asthma should boost the pairing of digital technologies with drugs.

Digital Health Clinical Trials

Crescendo Touts Rheumatoid Arthritis Dx Data Haul At ACR2016

Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, is talking-up the results of four different clinical trials of its Vectra DA multi-analyte blood test for rheumatoid arthritis that were presented at this year's American College of Rheumatology meeting in Washington, DC.

In Vitro Diagnostics Innovation

St. Jude: Neuromodulators Could Be Key To Fighting Opioid Epidemic

As public-health officials continue to fight the opioid epidemic, a top executive at St. Jude Medical says neuromodulators can play a central role in providing better treatment options.

Medical Device Business Strategies

OUS Approvals Analysis: Edwards, Medtronic, Ra Medical Headline A Very Slow Month For Non-US Approvals

Medical devices approved outside the US in October include Medtronic's CoreValve Evolut R, Edwards' Acumen Hypotension Probability Indicator, and two approvals – for two completely different indications – for Ra Medical Systems' excimer laser technology.

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